cardizem la Drug Patent Profile

Which patents cover Cardizem La, and what generic alternatives are available?

Cardizem La is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardizem La

A generic version of cardizem la was approved as diltiazem hydrochloride by TEVA on May 31^st, 1995.

Summary for cardizem la

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	10
Patent Applications:	3,360
Drug Prices:	Drug price information for cardizem la
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cardizem la
What excipients (inactive ingredients) are in cardizem la?	cardizem la excipients list
DailyMed Link:	cardizem la at DailyMed

See drug prices for cardizem la

See drug sales revenues for cardizem la

Recent Clinical Trials for cardizem la

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	Early Phase 1
CAMC Health System	Phase 4
University of South Florida	N/A

See all cardizem la clinical trials

Pharmacology for cardizem la

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Paragraph IV (Patent) Challenges for CARDIZEM LA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	120 mg, 180 mg, 240 mg, 300 mg and 360 mg	021392	1	2005-08-30
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	420 mg	021392	1	2005-04-25

US Patents and Regulatory Information for cardizem la

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-001	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-002	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003	AB	RX	Yes	Yes
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003	AB	RX	Yes	No

Expired US Patents for cardizem la

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-002	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003

International Patents for cardizem la

See the table below for patents covering cardizem la around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	60042168
European Patent Office	0591424	DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM)
Austria	184196
Germany	60019550
World Intellectual Property Organization (WIPO)	0141744
Canada	2348953	BILLES DE CIRE DE REMBOURRAGE POUR LA FABRICATION D'ARTICLESDE FORME SOLIDE (CUSHIONING WAX BEADS FOR MAKING SOLID SHAPED ARTICLES)
Spain	2241637

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CARDIZEM LA

Last updated: July 27, 2025

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Introduction

CARDIZEM LA (long-acting verapamil) is a pivotal calcium channel blocker primarily indicated for managing hypertension, angina pectoris, and certain arrhythmias. As a flagship product within the cardiovascular therapeutics segment, its market performance hinges on a confluence of regulatory, clinical, and economic factors. This report dissects the current market dynamics, assesses competitive positioning, and projects the financial trajectory for CARDIZEM LA amidst evolving healthcare landscapes.

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Market Overview and Therapeutic Position

Verapamil, branded as CARDIZEM LA among other formulations, has established a significant footprint within the calcium channel blocker (CCB) category. Its extended-release formulation offers sustained plasma drug levels, improving patient adherence compared to immediate-release counterparts. According to GlobalData, the global cardiovascular drug market is projected to reach USD 146 billion by 2027, with CCBs comprising a substantial share, driven by aging populations and rising hypertension prevalence worldwide.

CARDIZEM LA’s therapeutic niche is reinforced by its once-daily dosing regimen, a key factor in improving compliance among hypertensive and angina patients. In developed markets like North America and Europe, physicians favor long-acting formulations due to their improved safety profile and convenience, further bolstering sales potential.

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Market Dynamics Influencing CARDIZEM LA

Regulatory Environment

Regulatory approvals in major markets have historically provided a stable foundation for CARDIZEM LA. The US FDA-approved formulation ensures an enforceable market share within the United States, while the European Medicines Agency (EMA) offers parallel approval processes elsewhere. However, patent expirations pose critical risks; the original patent for VERAPAMIL's extended-release form expired in the late 2000s, prompting a shift toward generic competition.

The entry of generics significantly affects pricing strategies and market share. The Food and Drug Administration (FDA) approved numerous generic versions, intensifying price competition. Consequently, brand reliance diminishes unless differentiated by formulation or clinical benefits.

Competitive Landscape

The calcium channel blocker segment is highly competitive, featuring generics, fixed-dose combinations, and newer agents like amlodipine and diltiazem. The primary challenge for CARDIZEM LA is maintaining its market share against generic verapamil sustained-release formulations, which often price lower while providing similar efficacy.

Innovations that offer improved bioavailability, reduced side effects, or combination therapy advantages are critical to differentiation. Last decade's introduction of so-called “smart formulations” has further fragmented the market.

Clinical Guidelines and Prescribing Trends

Guidelines from the American Heart Association and European Society of Cardiology favor CCBs as first-line agents for hypertension, especially in specific populations such as African Americans and elderly patients. The evidence backing CARDIZEM LA’s efficacy aligns with these recommendations, supporting steady prescribing rates.

However, clinicians increasingly prefer fixed-dose combination regimes (e.g., CCB plus ACE inhibitors) for better blood pressure control, which may influence the demand for standalone formulations like CARDIZEM LA.

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Market Drivers and Challenges

Drivers:

• Aging populations globally elevating the prevalence of hypertension and angina.
• Rising awareness of cardiovascular health.
• Patient preference for once-daily formulations enhancing compliance.
• Clinical guideline support favoring CCBs as first-line agents.

Challenges:

• Patent expiration and competition from generics lowering prices.
• Market saturation in mature regions.
• Price pressures from national health services and payers.
• Emergence of novel therapies with better safety profiles or targeted mechanisms.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Historical data indicates that innovative formulations of verapamil, including CARDIZEM LA, achieved peak revenues shortly after regulatory approval, bolstered by clinical efficacy and patient adherence benefits. However, subsequent generic proliferation caused a steep decline in brand-specific sales.

Projection Scenarios

1. Conservative Scenario:
   As patent losses deepen, revenues decline by approximately 15–20% annually over the next five years due to generic competition, stabilizing at a lower baseline as the market consolidates.

2. Moderate Growth Scenario:
   Strategic differentiation through formulation improvements, positive real-world data, or combination therapies leads to a modest rebound, with revenues stabilizing or growing at 2–4% annually, especially in emerging markets.

3. Aggressive Innovation Scenario:
   Launch of next-generation formulations, biosimilars, or combination therapies could revive revenue streams, potentially realizing a 5–8% annual growth within the next five years.

Overall, unless driven by innovation or expansion into newer markets, CARDIZEM LA’s revenue stream is expected to face a downward trajectory primarily dictated by generic erosion.

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Emerging Opportunities and Risks

Opportunities:

• Expansion into underpenetrated emerging markets with increasing cardiovascular disease prevalence.
• Developing fixed-dose combination products, enhancing treatment adherence.
• Leveraging pharmacoeconomic studies to reinforce cost-effectiveness and secure formulary inclusion.

Risks:

• Patent expirations leading to generic onslaught.
• Increasing price sensitivity among payers.
• Regulatory hurdles in emerging markets.
• Competition from novel classes such as angiotensin receptor blockers or endothelin antagonists.

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Strategic Recommendations

• Innovation Focus: Invest in formulation enhancements or combination therapies to differentiate CARDIZEM LA from generics.
• Market Expansion: Target emerging markets with rising cardiovascular disease burdens.
• Cost Optimization: Adapt pricing strategies to meet payer expectations without compromising margins.
• Clinical Evidence: Strengthen the value proposition through real-world data and comparative effectiveness research.

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Key Takeaways

• The CARDIZEM LA market faces significant headwinds due to patent expirations and generic competition, but sustained demand persists in hypertension and angina management.
• Long-term revenue projections suggest a declining trend unless product differentiation or innovation occurs strategically.
• Market success will depend on expanding into emerging markets, optimizing pricing models, and enhancing clinical value through innovative formulations.
• Prescriber trends favor long-acting formulations aligned with guideline recommendations, maintaining relevance amid competitive dynamics.
• A comprehensive approach combining innovation, market expansion, and value demonstration can optimize CARDIZEM LA's financial trajectory.

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FAQs

1. How does patent expiry affect CARDIZEM LA’s market potential?
Patent expiration facilitates generic entry, dramatically lowering prices and market share for the branded product, often leading to revenue declines unless differentiating strategies are employed.

2. What factors could revive the revenue potential of CARDIZEM LA?
Innovative formulation improvements, introduction of combination therapies, expansion into emerging markets, and strong real-world evidence supporting its clinical advantages can help rejuvenate revenues.

3. How do clinical guidelines influence CARDIZEM LA’s market?
Guideline endorsement of CCBs for hypertension and angina sustains prescribing rates, reinforcing demand, especially if real-world data confirms its safety and efficacy.

4. In which markets does CARDIZEM LA have the highest growth potential?
Emerging economies with increasing cardiovascular disease prevalence, expanding healthcare infrastructure, and rising treatment rates represent the most promising growth sectors.

5. What competitive strategies can pharmaceutical companies employ to sustain CARDIZEM LA's market share?
Differentiating through formulation innovation, strategic pricing, educating prescribers, developing fixed-dose combinations, and geographic expansion are key approaches to maintaining market position.

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References

[1] GlobalData. (2022). Cardiovascular Drugs Market Forecast.
[2] American Heart Association. (2021). Guidelines for Hypertension Management.
[3] U.S. Food and Drug Administration. (2020). Verapamil Extended-Release Approval Notes.
[4] European Society of Cardiology. (2022). Management of Hypertension and Angina.
[5] IQVIA. (2022). Global Cardiovascular Therapeutics Market Analysis.